FDA.reportPublic FDA data

Application 204876

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BIVALIRUDINBIVALIRUDININJECTABLE;INTRAVENOUS250MG/VIALNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204876-001BIVALIRUDINBIVALIRUDIN250MG/VIALINJECTABLE / INTRAVENOUS2017-07-06

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A204876-001BIVALIRUDIN250MG/VIALINJECTABLE / INTRAVENOUS2017-07-06f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A204876-001BIVALIRUDIN250MG/VIALINJECTABLE / INTRAVENOUS2017-07-06e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A204876-001BIVALIRUDIN250MG/VIALINJECTABLE / INTRAVENOUS2017-07-06cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A204876-001BIVALIRUDIN250MG/VIALINJECTABLE / INTRAVENOUS2017-07-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A204876-001AP174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A204876-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A204876-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A204876-001AP1ea99ee380514…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BivalirudinBIVALIRUDINAvenacy, LLC42aa2630-83d6-433d-8277-0f672cf8d71d2026-08-20Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
BIVALIRUDINBIVALIRUDINEugia US LLCe574d04f-67b4-4a84-9d66-8c2d54f951202026-07-10Warnings, Adverse reactionsName fallback
brand name: BIVALIRUDIN
generic name: BIVALIRUDIN
bivalirudinBIVALIRUDINCivica, Inc.19a4afc5-151d-4d3c-bfef-48aa8797d6952025-09-10Warnings, Adverse reactionsName fallback
brand name: bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINFresenius Kabi USA, LLC50975be1-6d1f-497c-b989-1825a0fae1a72025-08-27Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINFresenius Kabi USA, LLCaf943fa0-ab0f-4b62-9ff0-54ee24cdb7722025-05-08Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINMylan Institutional LLC95d150e7-f152-4091-b831-e469c9578a542025-03-24Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINHainan Shuangcheng Pharmaceuticals Co., Ltd.61de12ff-e280-4bab-9804-43869ec45fa72024-12-23Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINAccord Healthcare, Inc.c20969cb-72d4-469b-9bd8-332250d896c32024-08-15Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINMAIA Pharmaceuticals, Inc.c727199d-f4cd-4658-8fdf-568590beface2024-05-27Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
BIVALIRUDINBIVALIRUDINMeitheal Pharmaceuticals Inc.26fb46f6-0088-42b8-b6f2-c672247768032024-04-04Warnings, Adverse reactionsName fallback
brand name: BIVALIRUDIN
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINPar Health USA, LLC91cf9d00-29e0-4357-a184-f70026c47edb2024-03-01Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN
bivalirudinBIVALIRUDINSlate Run Pharmaceuticals, LLC5d9a45c6-e234-4d56-9132-5e24e65852e62021-06-09Warnings, Adverse reactionsName fallback
brand name: bivalirudin
generic name: BIVALIRUDIN
BIVALIRUDINBIVALIRUDINMeitheal Pharmaceuticals Inc.4119b710-ef30-4e3e-b99a-38e42b4b3fca2021-06-08Warnings, Adverse reactionsName fallback
brand name: BIVALIRUDIN
generic name: BIVALIRUDIN
bivalirudinBIVALIRUDINSandoz Incce56f806-7845-429d-a1ce-c2dbf79b22eb2019-09-30Warnings, Adverse reactionsName fallback
brand name: bivalirudin
generic name: BIVALIRUDIN
BivalirudinBIVALIRUDINDr. Reddy's Laboratories Limited19beb2ae-6064-3c24-fe50-0cee868969792019-07-16Warnings, Adverse reactionsName fallback
brand name: Bivalirudin
generic name: BIVALIRUDIN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60505-6101BivalirudinbivalirudinApotex corpANDACurrent
60505-6101BivalirudinbivalirudinApotex corpANDACurrent
60505-6101BivalirudinbivalirudinApotex corpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
48943ORIG2017-07-11